Systems and methods for treatment of perforator veins for venous insufficiency

Abstract

Systems and methods for the treatment of perforator veins for venous insufficiency are described. The systems can include a catheter assembly comprising a proximal hub, a spin lock on the proximal hub, a elongate body overmolded to the proximal hub, and a distal end, the catheter, the elongate body configured to be placed within a perforator vein; an extension tubing having a proximal female hub, a distal male hub, and an elongate body therebetween, the distal male hub having a spin lock thereon, the distal male hub configured to be attached to the proximal hub of the catheter assembly; a syringe filled with a volume of media including cyanoacrylate; and an injector configured to automatically dispense a bolus of the media sufficient to coapt the perforator vein from the syringe upon actuation of a control on the injector. Methods are also disclosed.

Description

[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 925,478, which was filed on Jan. 9, 2014 and is entitled, “SYSTEMS AND METHODS FOR TREATMENT OF PERFORATOR VEINS FOR VENOUS INSUFFICIENCY,” the entire content of which is incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Healthy leg veins contain valves that allow blood to move in one direction from the lower limbs toward the heart. These valves open when blood is flowing toward the heart, and close to prevent venous reflux, or the backward flow of blood. When veins weaken and become enlarged, their valves cannot close properly, which leads to venous reflux and impaired drainage of venous blood from the legs. Venous reflux is most common in the superficial veins. The largest superficial vein is the great saphenous vein (GSV), which runs from the top of the foot to the groin, where it terminates at the saphenofemoral junction. There are veins which lead from the superficial veins (great a...

AI Technical Summary

Benefits of technology

The patent describes a system and method for treating a condition called venous insufficiency. The system includes a catheter assembly with a distal end that is placed within a patient's vein through a needle. A syringe is attached to the catheter assembly and contains a substance called cyanoacrylate. The substance is injected through the catheter into the vein to fill it and improve its function. An injector is used to control the injection. The method involves advancing a catheter and injecting the media into the vein, then withdrawing the catheter and applying pressure to coapt the vein. The technical effect of the patent is to provide a system and method for treating venous insufficiency that allows for accurate placement of the catheter and safe and effective injection of the media.

Problems solved by technology

When veins weaken and become enlarged, their valves cannot close properly, which leads to venous reflux and impaired drainage of venous blood from the legs.

This could compound the general symptoms of venous reflux, creating additional venous hypertension throughout the region where the perforator is located.

These sites are often associated with skin degradation leading to venous stasis ulcers.

Radiofrequency and laser ablation often require tumescent anesthesia which produces both bruising and pain along the treatment zone for several days post-procedure.

Both can have side effects such as burns and nerve damage, each of which can result in paresthesia or hypoesthesia.

Radiofrequency and laser ablation also can require expensive radiofrequency devices and / or laser boxes in addition to expensive single use disposable components.

In addition, these methods are often challenging to perform.

The perforating veins typically are tortuous and short in length (e.g., between about 2 and about 7 cm), making the steps of needle access, positioning a laser fiber or RF catheter and injecting tumescent anesthesia technically difficult.

And while foam sclerotherapy is relatively non-invasive, it is known to have a high rate of recurrence and potentially undesirable side effects.

Despite its popularity, ultrasound visualization often provides inadequate resolution for careful intravenous placement of a catheter for the treatment of venous reflux disease, and improved echogenic catheters and methods of use are needed.

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